SLND Versus Non-Dissection Following ESD for T1a Stage Esophageal Squamous Cell Carcinoma

Not Applicable

Not yet recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT06979986
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

This is a study from Fujian Cancer Hospital Thoracic of Surgery Project, numbered as FJCHTOSP-1. Systematically mediastinal Lymph Node Dissection (SLD) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma: a single-center, prospective clinical trial.

Detailed Description

Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the systematically mediastinal lymph node dissection (SLND) group will receive systematically mediastinal lymph node dissection, while those in the non-SLND group will not receive mediastinal lymph node dissection. The primary endpoint is 3-year disease-free survival (DFS).

The sample size are estimated with reference to investigators' previous data, in which the 3-year DFS was 62.7% for patients diagnosed with T1a Stage Esophageal Squamous Cell Carcinoma and underwent Endoscopic Submucosal Dissection without SLND. Investigators assumed that if 3-year DFS of patients in SLND group was over 80%, then investigatorswould deem the SLND group to be superior to the non-SLND group. The sample size are estimated to be 102. Therefore, the total number of patients enrolled are designed to be 102.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-01
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Clinical stage T1aN0M0.
• A lesion detected on Endoscopic Ultrasound featured as T1a stage.
• Age 18 to 75.
• Patients who have signed the informed consent form.

Exclusion Criteria

• • Other than invasive adenocarcinoma by pathological analysis.

  • Not complete resected or curative intent.
  • Patients who have history of other malignant tumors.
  • Patients who have history of thoracic surgery.
  • Patients who have received radiation, chemotherapy or other treatments previously.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DFS	From enrollment to the end of treatment at 3 years	disease-free survival